Average Ratings 0 Ratings
Average Ratings 0 Ratings
Description
The Drug Safety Triager, developed by Clarivate, represents an advanced pharmacovigilance tool aimed at helping life sciences organizations adhere to regulatory standards. This system, which is validated for Good Practice (GxP) compliance and prepared for audits, enhances and organizes the workflow associated with literature reviews, allowing pharmacovigilance professionals to prioritize patient safety by streamlining these processes. Fully compliant with the reporting demands of major global safety regulatory bodies, including the FDA and EMA, the Drug Safety Triager includes a comprehensive validation package with every implementation. The validation documentation is carefully constructed to meet the stringent requirements set forth by the pharmaceutical sector and health authorities. Additionally, every piece of literature referenced is subjected to a meticulous review process that ensures all user actions are recorded, creating a permanent, immutable audit trail for accountability and transparency. This innovative approach not only improves efficiency but also reinforces the commitment to maintaining high standards in patient safety and regulatory compliance.
Description
Kneat Gx is a cloud-based validation lifecycle management platform developed by Kneat Solutions for organizations operating in regulated life sciences industries. The software digitizes validation activities by replacing paper-based documentation, manual testing processes, and disconnected approval workflows with a centralized electronic system. Its configurable workflows support computer system validation, equipment qualification, cleaning validation, process validation, and other GxP activities. Users can create and manage requirements, risk assessments, validation plans, protocols, test scripts, and summary reports within the platform. Automated requirements traceability matrices connect requirements, risks, and test evidence to help teams monitor validation coverage and identify gaps. Electronic test execution, digital signatures, approval workflows, and secure audit trails support compliance with applicable regulatory requirements. Kneat Gx includes AI-powered tools for generating validation documentation, reviewing records, and retrieving information through natural language questions. Its reporting dashboards provide visibility into validation progress, outstanding tasks, document status, and operational performance across projects and locations. The platform also offers configurable templates, document management, equipment data management, and API integrations to support standardized validation processes throughout an organization.
API Access
Has API
No
API Access
Has API
No
Integrations
No details available.
Integrations
No details available.
Pricing Details
No price information available.
Free Trial
No
Free Version
No
Pricing Details
No price information available.
Free Trial
No
Free Version
No
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
No
iPad App
No
Android App
No
Windows
No
Mac
No
Linux
No
Chromebook
No
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
No
iPad App
No
Android App
No
Windows
No
Mac
No
Linux
No
Chromebook
No
Customer Support
Business Hours
Yes
Live Rep (24/7)
No
Online Support
Yes
Customer Support
Business Hours
Yes
Live Rep (24/7)
No
Online Support
Yes
Types of Training
Training Docs
Yes
Webinars
No
Live Training (Online)
Yes
In Person
Yes
Types of Training
Training Docs
Yes
Webinars
Yes
Live Training (Online)
Yes
In Person
No
Vendor Details
Company Name
Clarivate
Country
United Kingdom
Website
clarivate.com/life-sciences-healthcare/research-development/pharmacovigilance-drug-safety/drug-safety-triager/
Vendor Details
Company Name
Kneat
Founded
2006
Country
Ireland
Website
kneat.com
Product Features
Product Features
Document Management
Access Controls
No
Archiving & Retention
No
Collaboration Tools
No
Compliance Tracking
No
Document Archiving
No
Document Assembly
No
Document Capture
No
Document Conversion
No
Document Delivery
No
Document Indexing
No
Document Retention
No
Electronic Signature
No
Email Management
No
File Recovery
No
File Type Conversion
No
Forms Management
No
Full Text Search
No
Offline Access
No
Optical Character Recognition
No
Print Management
No
Version Control
No